Bleeding Pattern Study - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00302666

Purpose

The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.

Condition	Intervention	Phase
Contraception, Bleeding Pattern	Drug: Marketed product: Valette®	Phase III

Drug Information available for: Ethinyl estradiol Dienogest

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparative, Prospective, Multi-Center, Open, Randomized Study to Investigate Bleeding Patterns, Metabolic Effects, Contraceptive Efficacy, Acceptance, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 2 mg Dienogest, in Two Different Regimens of Intake (Four Extended Cycles of 84 Days Each Versus the Conventional Regimen of 21 Days) in Healthy Volunteers

Further study details as provided by Bayer:

Primary Outcome Measures:

Bleeding pattern

Secondary Outcome Measures:

Safety, contraceptive efficacy

Study Start Date:

June 2003

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy female volunteers aged between 18 and 40 years requiring contraception.

Exclusion Criteria:

Pregnancy or lactation.
Any conditions that might interfere with the outcome as well as all contraindications for OC use.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302666

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Schering Pharma AG, Germany, Medical Affairs

phone: +49 30 46811800

More Information

Study ID Numbers:	306903
Study First Received:	February 23, 2006
Last Updated:	April 30, 2007
ClinicalTrials.gov Identifier:	NCT00302666
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Ethinyl Estradiol
Healthy
Hemorrhage
Dienogest

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009